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Atherectomy peripheral angioplasty system - ARTG 481673

Access comprehensive regulatory information for Atherectomy peripheral angioplasty system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 481673 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Medtronic Inc in United States of America. The device registration started on March 04, 2025.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
ARTG 481673
Class IIb
Atherectomy peripheral angioplasty system
ARTG ID: 481673
Good Name: Medtronic Australasia Pty Ltd - Atherectomy peripheral angioplasty system
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Intended Purpose

The driver used in conjunction with a catheter is intended to restore blood flow by removing atherosclerotic calcified and non-calcified plaque from peripheral arteries to maximize luminal gain.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481673
Start Date
March 04, 2025
Effective Date
March 04, 2025
Manufacturer
Country
United States of America
Address
710 Medtronic Parkway, Minneapolis, MN, 55432